Label: FAMOTIDINE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 4, 2024

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  • Drug Facts

    Active ingredient(in each tablet)
    Famotidine 20 mg

  • PURPOSE

    Purpose
    Acid reducer

  • Uses

    • relieves heartburn associated with acid indigestion and sour stomach.
    • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.
  • WARNINGS

    Allergy alert: Do not use if you are allergic to famotidine or other acid reducers.

    Do not use

    • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
    • with other acid reducers

    Ask a doctor before use if you have

    • had heartburn over 3 months. This may be a sign of a more serious condition.
    • heartburn with lightheadedness, sweating, or dizziness
    • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain
    • kidney disease

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

    Stop use and ask a doctor if

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • your heartburn continues or worsens
    • you need to take this product for more than 14 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

  • Directions

    • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • read the directions and warnings before use
    • store at 20°-25°C (68°-77°F)
    • protect from moisture
    • meets USP Dissolution Test 2
  • INACTIVE INGREDIENT

    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide.

  • QUESTIONS

    Questions or comments?

    1-800-231-4670:
    weekdays 9am-5pm EST

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313

    *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Pepcid AC®.

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • PRINCIPAL DISPLAY PANEL

    NDC 70000-0710-1

    Maximum Strength

    Acid Reducer

    Famotidine Tablets USP, 20 mg

    Just One Tablet Prevents
    & Relieves Heartburn Due
    to Acid Indigestion

    COMPARE TO MAXIMUM STRENGTH PEPCID AC® active ingredient*

    200
    TABLETS

    Leader Label

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0710
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;29
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0710-11 in 1 CARTON12/04/2024
    1200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21800312/04/2024
    Labeler - Cardinal Health (063997360)
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